BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE BIFURCATED STENT GRAFT

    MDR report key: 2010918 · Received March 4, 2011

    Report

    Report Number
    2953200-2011-00598
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ENDOLEAK, RUPTURED ANEURYSM/VESSEL. DISEASE PROGRESSION. CONCLUSIONS: LACK OF EFFECTIVENESS, DISEASE PROGRESSION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 66 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ABDOMINAL AND BACK PAIN APPROXIMATELY 1 MONTH AGO AND WAS FOUND TO HAVE HAD A CONTAINED RUPTURED ANEURYSM. THE RUPTURE WAS ATTRIBUTED TO DISEASE PROGRESSION, AS THE ANEURYSM HAD EXPANDED AND TAKEN UP THE AORTIC NECK. A PROXIMAL TYPE I ENDOLEAK AND THROMBUS AROUND THE STENT GRAFT WAS NOTED; HOWEVER, THERE WAS NO MIGRATION. THE PHYSICIAN ELECTED TO EXPLANT THE BIFURCATED STENT GRAFT AND CUT OFF THE CONTRALATERAL LIMB AND THEN SEW IN A DACRON GRAFT WITH SUCCESSFUL RESULTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE EXPLANTED STENT GRAFTS WERE DISCARDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE BIFURCATED STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR NA V00001725

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention